Kornimate/medical-research-clean huggingface dataset:
an rct of a telemedicine intervention for hypokinetic dysarthria in pd

Conditions: Parkinson's Disease

Summary: nearly 90% of people with parkinson's disease have speech and voice disorders that negatively impact their ability to communicate effectively in daily life. this study will test the hypothesis that a combined speech and exercise intervention will improve speech intelligibility in people with parkinson's disease and speech impairment. this approach would offer an affordable way to continue to both instruct and encourage training by veterans virtually indefinitely through the remote access technology. these findings may help va clinicians provide optimal care for the many veterans with parkinson's disease and speech impairment.

background/rationale the great majority of individuals with parkinson's disease (pd) develop speech impairments, most of which are grouped together and called hypokinetic dysarthria. hypokinetic dysarthria is typically characterized by altered prosody (e.g., reduced loudness and pitch variation), phonation (e.g., breathy or harsh voice), and articulation (e.g., imprecise consonants, centralized vowels). changes in speech may appear early in pd and progress in severity over time. further, such changes in speech lead to significant declines in functional communication and quality of life. pharmacological and surgical interventions that alleviate motor symptoms in pd are largely ineffective or sometimes even detrimental for speech. objectives based on results from a preliminary study, the investigators propose to conduct a pilot randomized, controlled trial in patients with hypokinetic dysarthria in pd to assess the potential effectiveness of a novel home-based exercise intervention with interactive automated speech response features that encourage a higher level of speech performance. the investigators hypothesize that patients in the intervention program will improve in speech intelligibility and self-perceived communication ability over 6 months, as compared with patients in a health education program. methods a total of 104 community-dwelling veterans with hypokinetic dysarthria in mild-to-moderate pd will be randomly assigned to the exercise intervention or to the health education control. the investigators will test the effects of the intervention at 6 months for the outcomes speech intelligibility and self-perceived communication ability.

Eligibility criteria:
inclusion criteria: * physician diagnosis of idiopathic parkinson's disease (pd) * at least 2 of the 3 cardinal signs of pd (resting tremor, rigidity, bradykinesia) * response to dopaminergic medication * hypokinetic dysarthria exclusion criteria: * angina pectoris * history of myocardial infarction (mi) within 6 months * history of ventricular dysrhythmia requiring current therapy

Keywords: parkinson's disease dysarthria speech therapy
uae-prime: a feasibility study of a precise robotically implanted brain-computer interface for the control of external devices

Conditions: Tetraplegia/Tetraparesis; Quadriplegia; Quadriplegia/Tetraplegia; Cervical Spinal Cord Injury; Amyotrophic Lateral Sclerosis (ALS); Spinal Cord Injury (Quadraplegia); Spinal Cord Injury; Motor Neuron Disease; Brain Stem Stroke

Summary: the uae-prime study is a feasibility study designed to assess the initial clinical safety and functionality of the neuralink n1 implant and r1 robot. this study involves participants who have tetraparesis, tetraplegia, or a diagnosis that may lead to these conditions. the n1 implant is a wireless, rechargeable device mounted on the skull, connected to electrode threads that are inserted into the brain by the r1 robot, which is a robotic device specifically designed for this procedure.


Eligibility criteria:
inclusion criteria: * (a) a diagnosis of a spinal cord injury (\>12 months), stroke (\>12 months), or other neurological condition causing the participant to experience bilateral upper limb motor impairment, with no expectation of recovery. or (b) a diagnosis of amyotrophic lateral sclerosis (als) or other progressive neurological condition where the natural history of the disease is well understood and where there is tetraparesis and the expectation, in the view of the participant's treating neurologist, that the disease will progress such that the participant will meet criteria 1a within 1 year of recruitment. * life expectancy ≥ 12 months. * ability to communicate verbally or with the use of a computer or communication aid, and working proficiency in english. * presence of a stable caregiver exclusion criteria: * moderate to high risk for serious perioperative adverse events * morbid obesity (body mass index \> 40) * history of poorly controlled seizures or epilepsy * history of poorly controlled diabetes * requires magnetic resonance imaging (mri) for any ongoing medical conditions * acquired or hereditary immunosuppression * smoking tobacco or use of other tobacco products \> once per month within the last year. * psychiatric or psychological disorder * pre-existing damage to the cortical region of interest (as determined by mri) * any condition which, in the opinion of the investigator, would compromise your ability to safely participate in the study or undergo the implantation procedure

Keywords: brain computer interface neuralink n1 implant neuralink robot tetraparesis tetraplegia quadriplegia als spinal cord injury amyotrophic lateral sclerosis chip brain chip external device control wireless implant neuroprosthetics sci paralysis motor neuron disease
jupiter 4.0 - risk factors for failure of isolated medial patellofemoral ligament reconstruction

Conditions: Patellar Dislocation, Recurrent; Patellar Dislocation; Patellar Instability; Patellofemoral Dislocation; Patellofemoral Joint Dislocation; Patellofemoral Disorder

Summary: the goal of this observational study is to learn about the outcomes of medial patellofemoral ligament (mpfl) reconstruction for the treatment of recurrent patellar instability. the main questions it aims to answer are: * what are the risk factors for recurrent patellar instability after mpfl reconstruction? * what functional outcomes do patients report after mpfl reconstruction? participants undergoing mpfl reconstruction will answer survey questions about their knee and activity level 1 year and 2 years after surgery.

the jupiter group consists of high-volume patellofemoral surgeons across the united states, and was organized to facilitate the collection of clinical and radiographic outcomes following surgical and non-surgical treatment of patellar instability. with this study (jupiter 4.0), the group aims to prospectively enroll a new cohort of consecutive patients with recurrent patellar instability that would undergo isolated mpfl reconstruction regardless of radiographic measurements or anatomic risk factors to address two specific aims - 1) what patient, injury, and surgical factors lead to recurrent instability following isolated mpfl reconstruction and 2) the creation of an instability severity index score, with the long-term objective of identifying preoperatively, patients with a high risk of failure of an isolated mpfl reconstruction who may be better served with concomitant bony procedure.

Eligibility criteria:
inclusion criteria: * 10-35 years old * recurrent patellar instability with at least one episode defined as either (1) a dislocated patella requiring reduction in the emergency department or (2) a convincing history for dislocation, associated with full giving way, and the following physical findings: (a) hemarthrosis or effusion, (b) tenderness along the medial retinaculum, and (c) apprehension when laterally directed force was applied to the patella or (3) mri-documented dislocation with associated bone bruises exclusion criteria: * previous ipsilateral knee surgery * obligatory/fixed/habitual patella dislocation or subluxation * unloadable inferior or lateral chondral damage on the patella that would require a tibial tubercle transfer for unloading purposes * pathologic tibiofemoral instability

Keywords: patella patella dislocation patellar instability recurrent patellar instability mpfl medial patellofemoral ligament medial patellofemoral ligament reconstruction patellofemoral instability
probiotic supplementation to improve the gut microbiota of very low birth weight preterm, a pilot study

Conditions: Other Preterm Infants; NEC

Summary: this pilot trial is designed to investigate the benefits of the use of probiotics in gut microbiota development and/or immunological biomarkers and how this can be related with the clinical status of very low birth weight preterms during their first weeks of life at the neonatal intensive care unit(nicu).

this pilot trial is designed to investigate the benefits of the use of mixtures of probiotics isolated from human milk in gut microbiota development and/or immunological biomarkers. furthermore, the relationship between evaluated parameters and the clinical status of very low birth weight preterms during their first weeks of life at the nicu will be analysed.

Eligibility criteria:
inclusion criteria: * preterm infants with birth weight less than one thousand and three hundred grammes * preterm infants with gestational age less than 29 weeks exclusion criteria: * mayor malformations * chromosomopathies * congenital infections * non parental consent

Keywords: vlbw preterm gut microbiota probiotics supplementation immune compounds
bimodal, cros and severe profound hearing loss study

Conditions: Cochlear Implant; Severe-Profound Hearing Loss; Hearing Loss, Bilateral; Hearing Loss, Cochlear

Summary: the study will involve the comparison of three groups with severe-profound hearing loss. patients with a cochlear implant only, patients with a cochlear implant and hearing aid, and finally patients with two hearing aids. this will enable a comparison of standard fitting protocols against the new rationale using the same devices. devices used for patients in all 3 groups are now available in standard of care, and can be kept afterwards should the patients wish.

the study will involve three groups of 20 patients per group. this first is experienced adult bimodal users of the ab system who have usable contralateral residual hearing. a clinical baseline and three research conditions will be evaluated. the naida ci link ha (link) will be fitted, tested and then optimised using a special bimodal fitting formula. subjects will be allowed three months to acclimatize and will then be retested. the second research condition will evaluate the fully integrated bimodal system, where the microphone signals from ci and ha are shared and a bilateral beamformer is formed. a third intervention will involve modifying the ci settings to minimize the mis-match between frequencies delivered via the ci. a second group with no aidable hearing on their non-implanted ear will also be studied. a contralateral routing of signal (cros) device will send sounds on the non-implanted side. tests will be made with and without cros, as well as with directional microphone settings. finally as a control group, bilateral ha users will be tested with the similar ha fitting as used for the bimodal group. this will enable a comparison of standard fitting protocols against the new rationale using the same devices.

Eligibility criteria:
inclusion criteria: * participant is willing and able to give informed consent for participation in the study. * male or female, aged 18 years or above. * consistent unilateral user of an advanced bionics cochlear implant and a contralateral hearing aid for at least 6 months, ideally 12 months, and bilateral severe to profound hearing loss (meeting nice criteria for implantation-2009). (group 1) * consistent unilateral user of an advanced bionics cochlear implant for at least 6 months and ideally 12 months, with no useful contralateral hearing (group 2) * consistent user of bilateral hearing aids for at least six months (group 3) and bilateral severe profound hearing loss (80db or worse at 2000 and 4000 hz with speech discrimination of at least 50% ihr sentences live voice at 60dba) * first language english * post-lingual onset of severe to profound hearing loss * no other handicaps that would interfere with participation in the study in the opinion of the principle investigator exclusion criteria: * unstable cochlear implant or hearing aid fitting * using medication in an intermittent manner that might influence hearing levels * cognitive or psychological challenges that might lead to variations in attention
success of inferior alveolar nerve block in women taking selective serotonin reuptake inhibitors

Conditions: Local Anesthesia

Summary: to evaluate the success of inferior alveolar nerve block (ianb) for mandibular molars with irreversible pulpitis in women under treatment with selective serotonin reuptake inhibitors (ssris).

seventy patients with a diagnosis of symptomatic irreversible pulpitis in one mandibular molar were assigned to either ssri users or ssri non-users groups. ssris users were 45 women who take ssris referred for endodontic treatment from a psychiatric clinic to the clinic of the endodontic department of isfahan university of medical sciences. ssris non-users were 45 women who did not take ssris referred for endodontic treatment to the same dental clinic. the protocol of the study was approved by the ethics committee of the university (no. 394867). written informed consent was obtained from all the patients. the level of anxiety of the patients was determined by using the corah dental anxiety scale. the patients registered their baseline pain severity using a heft-parker visual analogue scale (hp-vas). two standard ianbs (1.8-ml cartridges) of 2% lidocaine with 1:100,000 epinephrine (darupakhsh, tehran, iran) were administered to each patient. fifteen minutes after injection, the teeth were isolated. access cavity preparation was started. the patients was instructed by the same operator to mark his or her pain experienced during the access cavity preparation.

Eligibility criteria:
inclusion criteria: * vital mandibular molar tooth * diagnosis of symptomatic irreversible pulpitis exclusion criteria: * younger than 18 years old * history of significant medical conditions * allergies to local anesthetics or sulfites * pregnancy * active sites of pathosis in area of injection * inability to give informed consent

Keywords: inferior alveolar nerve block irreversible pulpitis selective serotonin reuptake inhibitor antidepressants
the purpose of the study is to gain an in-depth picture of the patient management and prescription behaviours

Conditions: Schizophrenia; Bipolar Disorders; Major Depressive Disorders

Summary: 'real life' retrospective patient cases (10) to provide an objective and robust analytical report of patient management and prescriptions behaviours for schizophrenia, bipolar disorders and major depressive disorders.


Eligibility criteria:
inclusion criteria: * patients diagnosed with one of the following conditions: schizophrenia, bipolar disorders and major depressive disorders. exclusion criteria: * patients who have not been diagnosed with the conditions as outlined in the inclusion criteria.
mfolfirinox as adjuvent chemotherapy in treating chinese pancreatic cancer patients

Conditions: Pancreatic Cancer

Summary: although folfirinox regimen was recently presented to be effective as adjuvant chemotherapy for resectable pancreatic cancer in selected patients who have good physical condition, there is still insufficient evidence on this regimen in treating resectable pancreatic cancer patients in china. since for many tumors, different races may show different responses to the same regimen, we design this open phase ⅱ study to evaluate the the efficacy and safety of mfolfirinox as adjuvant chemotherapy for resectable pancreatic cancer in china.

this is a phase ii study. patients with resectable pancreatic carcinoma will receive adjuvant chemotherapy of folfirinox for 6 months. primary endpoint is the disease free survival. secondary endpoints are overall survival, safety and quality of life.

Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma of the pancreas without distant metastases. * receive radical resection of pancreatic cancer * no prior cytostatic chemotherapy * female and male patients \> 18 and \<=79 years using contraception * ecog ≤ 1 * patient has adequate bone marrow and organ function * absolute neutrophil count (anc) ≥ 2.0 x 109/l platelets ≥ 90 x 109/l hemoglobin ≥ 90 g/l * patient has adequate liver function ast and alt not more than 2.5 times uln (not more than 5.0 times uln if there is liver metastasis) serum bilirubin ≤ 1.2 x uln creatinine ≤ 1.25 times uln * good compliance * written informed consent exclusion criteria: * pregnant or lactating women * distant metastasis. * patients with severe gastrointestinal hemorrhage which need frequent blood transfusions. * refuse to take appropriate contraceptive measures (including male patients). * allergic to oxaliplatin, irinotecan, leucovorin or 5-fluorouracil. * severe systemic disease out of control such as unstable or uncompensated respiratory, cardiac, liver, renal diseases. * patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment, (with the exception of non-melanoma skin cancer or cervical carcinoma in situ). * psychiatric illness that would prevent the patient from giving informed consent. * patient is concurrently using other antineoplastic agent * patient has used investigational antineoplastic agent within 4 weeks prior to entry. * known hiv-positivity. * no history of chronic diarrhea, nausea or vomit. * no ≥ grade 2 sensory peripheral neuropathy. * a history of transmural myocardial infarction (within 6 months prior to entry), congestive heart failure, and unstable angina. * infectious disease or inflammation with body temperature ≥ 38 ℃.

Keywords: pancreatic cancer adjuvant chemotherapy folfirinox
a clinical trial to examine the efficacy of a dietary supplement to improve the health and appearance of hair.

Conditions: Hair Thinning; Hair Shedding

Summary: this study evaluates the efficacy of scale media's hlv clinical formula hair vitamins on the health and appearance of hair, focusing on growth, volume, dullness, overall health, hair shedding, fullness, and strength. it is a randomized controlled trial with 50 female-at-birth participants experiencing self-perceived hair thinning.


Eligibility criteria:
inclusion criteria: * female at birth, aged 35+. * self-perceived hair thinning and increased hair shedding for at least three months. * consistent hair care routine for at least one month prior. * willing to maintain hair care routine, diet, and refrain from new vitamins or supplements targeting hair growth during the study. * generally healthy without uncontrolled chronic diseases. exclusion criteria: * hair loss conditions other than female pattern baldness. * pregnant, breastfeeding, or trying to conceive. * currently taking iron supplements or other hair growth treatments. * significant chronic conditions or planned medical procedures that interfere with protocol adherence. * recent chemical hair treatments or plans for such treatments during the study. * severe allergic reactions to the product's ingredients. * recent surgeries, major illnesses, or undergoing chemotherapy/radiotherapy.

Keywords: hair growth female pattern hair loss hair health
remote ischemic conditioning to reduce burn wound progression

Conditions: Burns

Summary: burned skin areas, which were initially vital, can be irreversibly damaged by wound progression. the aim of the present study is to evaluate the feasibility of ischemic conditioning to reduce secondary wound progression.


Eligibility criteria:
inclusion criteria: * ability to understand the study information and the consent to sign * thermal injury (burn / scalding) with a clinical evaluated depth of at least 2a (superficial partial) * at least one of the following sites must not have skin lesions : upper arm right and left * hospital admission within 6 hours after trauma has taken place exclusion criteria: * participation in another experimental study * pregnancy (women are subjected to a pregnancy test (urine) * contraindication for the use of the tourniquet, for example lymph drainage disorders after axillary lymphadenectomy or irradiation of the axilla * non-compliant patients who are, e.g. intubated * pure 3rd degree burns (full thickness) or charring * thermal injuries older than 6 hours
efficacy and safety study of the hs-25 combination with atorvastatin in subjects with hypercholesterolemia in coronary heart diseases

Conditions: Hypercholesterolemia in Coronaory Heart Disease

Summary: to determine the efficacy of hs-25 (20mg) in reducing low density lipoprotein-cholesterol (ldl-c) levels after a 12-week period of treatment in combination with atorvastatin in subjects with hypercholesterolemia and coronary heart diseases; to determine the safety of hs-25 (20mg) combination with atorvastatin in subjects with hypercholesterolemia and coronary heart diseases


Eligibility criteria:
inclusion criteria: * diet control for 14 weeks, atorvastatin 10mg once daily for 6 weeks or above; * the average of both qualifying values must be in the range of 2.07 mmol/l to 3.36 mmol/l. run-in (visit 2 and visit 3) and the visit 3 value must be within 12% of the value at visit 2, higher or lower; * must meet the one of diseases as following: 1. subjects who have stable coronary heart disease; 2. subjects who diagnosed ischemic stroke in stable condition; 3. subjects who diagnosed as diabetes mellitus exclusion criteria: * history of severe endiocrine disease (for example thyroid function abnormal); * history of advanced cancer * arrhythmias need to be treated by medications history of hemorrhagic stroke; * cardiac dysfunction; * unstable ascvd; * history of organ transplant; * hypersensitive to hs-25 or place; * uncontrolled or new diagnosed diabetes mellitus; * hcv and hbsag positive